IPR Pharmaceuticals, Inc. – FDA Warning Letter, Aug 31, 2020

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Sprout Pharmaceuticals regarding a direct-to-consumer (DTC) radio advertisement for ADDYI (flibanserin) tablets. The FDA determined the radio ad (US—1900289.03) misbrands Addyi by making false or misleading claims about risks and omitting material facts, violating 21 U.S.C. 352(n), 321(n), 331(a), and 21 CFR 202.1(e)(3)(ii), (iii); (e)(5).

The ad omits all contraindications and fails to adequately disclose material information from the Boxed Warning regarding severe hypotension and syncope risks when Addyi is used with alcohol, certain prescription medications, or in patients with liver problems. It also omits warnings about central nervous system depression and hypotension/syncope with Addyi alone. These omissions create a misleading impression of the drug's safety, which is particularly concerning given Addyi's Boxed Warning.

Furthermore, the ad creates a misleading impression of Addyi's approved indication and limitations of use by suggesting it's for all women "frustrated by their low libido," when it's specifically for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) not due to other conditions, relationship problems, or